Director, Clinical Operations (TMF)

Role Summary

The Director, Clinical Operations (TMF) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions. The individual leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Development (focus on Clinical Operations); serving as a change manager to implement new systems and practices that support the organization as we continue to grow. The individual is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group. This includes responsibility for the ‘What’ (delivery to performance goals) and the ‘How’ (deliver consistent with Summit Therapeutics core values). The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients. This position reports to a VP, Head of Clinical Operations.

Responsibilities

• Develop, implement, and oversee the CTMS and TMF systems and related processes
• Oversee TMF and CTMS vendors, contractors, and cross-functional teams
• Manage and develop existing TMF employees and lead by example by demonstrating our core values
• Develop, implement, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement
• Partner with key internal and external stakeholders to remediate risks and manage emerging issues
• Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards
• Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations
• Lead a team of TMF and CTMs colleagues and ensure their continuous development
• Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals
• Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS
• Participate as an active member of the Clinical Operations Extended Leadership Team (XLT)
• Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections
• Instill a culture of continuous improvement; acts as a change champion and effectively leads change
• Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution
• Travel on assignment, 25%

Qualifications

• Required: University degree (e.g. BA, BS or equivalent); preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred
• Required: 12 years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS)
• Required: Experience in managing/leading others
• Required: Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff
• Preferred: Experience in Phase III execution of clinical trials in Oncology
• Preferred: Previous regulatory inspection experience
• Required: Comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines
• Preferred: Solid vendor oversight experience including contracts and budget management

Education

• University degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred

Additional Requirements

• Travel on assignment, 25%